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2a- Pharmacology > Adverse drug reactions > Flashcards

Adverse drug reactions Flashcards

1
Q

What is an adverse drug reaction (ADR)?

A

A response to a medicinal product, or combination of medicinal products, which is noxious and unintended

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2
Q

Define side effects?

A

an unintended effect of a drug related to its pharmacological properties and can include unexpected benefits of treatment

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3
Q

What are examples of of mild ADRs?

A

nausea, drowsiness, itching rash

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4
Q

What are examples of severe ADRs?

A

respiratory depression, neutropenia, catastrophic haemorrhage, anaphylaxis

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5
Q

What is the first and secondary pharmacological effect of a beta blocker?

A

● Bradycardia and heart block are primary adverse effects
● Bronchospasm is a secondary pharmacological adverse effect

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6
Q

What is the Rawlins Thompson classification of ADRs?

A
  • Augmented
  • Bizarre
  • Chronic/continuing
  • Delayed
  • End of use/withdrawal
  • Failure of treatment
  • Genetic
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7
Q

Describe augmented ADRs

A
  • Most common type of ADR (80%)
  • Exaggerated effect of drugs pharmacology at a therapeutic dose
  • Often not life threatening
  • Dose dependent and reversible upon withdrawing the drug
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8
Q

Give an example of an augmented ADR

A

Bradycardia with betablockers

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9
Q

Describe bizarre ADRs

A
  • Not related to pharmacology of drug
  • Not dose related
  • Can cause serious illness or mortality
  • Symptoms do not always resolve upon stopping drug
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10
Q

Give an example of a bizarre ADR

A

Anaphylaxis with penicillin’s

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11
Q

Describe chronic/continuing ADRs

A

ADRs that continue after the drug has been stopped

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12
Q

Give an example of a chronic/continuing ADR

A

Osteonecrosis of the jaw with bisphosphonates

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13
Q

Describe delayed ADRs

A

ADRs that become apparent some time after stopping the drug

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14
Q

Give an example of a delayed ADR

A

Leucopenia with chemotherapy

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15
Q

Describe end of use/withdrawal ADRs

A

ADR develops after the drug has been stopped

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16
Q

Give an example of an end of use/withdrawal ADR

A

Rebound tachycardia after stopping beta-blocker

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17
Q

Describe failure of treatment ADRs

A
  • Unexpected treatment failure
  • Could be due to drug-drug interaction or drug-food interaction
  • Poor compliance with administration instructions
18
Q

Give an example of a failure of treatment ADR

A

Failure of bisphosphonate due to taking with food

19
Q

Describe genetic type ADRs

A

Drug causes irreversible damage to genome

20
Q

What is an example of a genetic ADR

A

Phocomelia in children of women taking thalidomide

21
Q

What is DoTS classification?

A
  • An alternative way to classify ADRs
    • Dose-relatedness
    • Timing
    • Susceptibility
22
Q

What are the 3 categories for dose-relatedness in DoTS?

A
  1. Hypersusceptibility
  2. Collateral effects (side effects)
  3. Toxic effects
23
Q

What is hypersusceptibility?

A

ADRs at subtherapeutic (smaller than normal) doses (eg anaphylaxis with penicillins)

24
Q

What are collateral effects?

A

ADRs at therapeutic doses (eg hypokalaemia with loop diuretic)

25
Q

What are toxic effects?

A

ADRs at subpratherapeutic (greater than normal) doses (eg liver damage with paracetamol)

26
Q

What are the 2 categories in timing in DoTS?

A
  1. Time independent
  2. Time dependent
27
Q

Describe time independent ADRs

A

ADRs which can develop during any time during treatment (often due to clinical changes in the patient)

28
Q

What are the categories of time dependent ADRs?

A

Rapid
First dose
Early
Intermediate
Late
Delayed

29
Q

What does susceptibility mean in DoTS?

A

Certain patient groups/populations may have a specific susceptibility to ADRs from a drug

30
Q

What are the categories for susceptibility in DoTS?

A
  • Age (anticholinergics in elderly patients)
  • Gender (metoclopramide in females)
  • Disease states (eg diclofenac in CVD)
  • Physiological states (eg phenytoin in pregnancy)
31
Q

What are ways to identify ADRs?

A
  • Pre-clinical testing (computer models, cells and toxicity testing in animals)
  • Clinical trial data (pre-marketing evaluation)
  • Post marketing surveillance
  • Pharmacovigilance
32
Q

What is a black triangle medicine?

A

Medicines subject to post marketing surveillance are indicated by a black triangle

33
Q

Should ADRs be listed as a black triangle medicine?

A

All ADRs should be reported for Black triangle medicines

34
Q

What are causes for ADRs?

A

● Pharmaceutical variation
● Receptor abnormality
● Drug-drug interactions

35
Q

When would you suspect an ADR?

A
  • Symptoms soon after a new drug is started
  • Symptoms after a dosage increase
  • Symptoms disappear when the drug is stopped
  • Symptoms reappear when the drug is restarted (rechallenge)
  • Patient concerns
36
Q

What are some common ADRs?

A

● Confusion
● Nausea
● Balance problems
● Diarrhoea
● Constipation
● Hypotension

37
Q

What is the yellow card scheme?

A

● The first ADR reporting scheme
● Collects spontaneous reports
● Acts as an ‘early warning system’ for identification of previously unrecognised reactions
● Provides information, about factors which predispose patients ADRs
● Continual safety monitoring of a product throughout its life span as a therapeutic agent

38
Q

Who are at increased risk to ADRs?

A
  • Atopic individuals
  • Females
  • Children/neonates
  • Reduced drug clearance
  • Polypharmacy
39
Q

What are some serious ADRs?

A
  • Caused hospitalisation
  • Prolonged hospitalisation
  • Life threatening
  • Causing disability or death
  • Causing congenital abnormalities
  • Deemed medically significant
40
Q

What 4 pieces of information would you include on a yellow card?

A

● Suspected drug
● Suspect reaction
● Patient details
● Reporter details

2a- Pharmacology (10 decks)

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